PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Technical Reports
Evaluation of High Voltage Leak Detector Applied to BFS (blow-fill-seal)
Norio ENTA
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2001 Volume 3 Issue 1 Pages 40-45

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Abstract

  During recent years, with respect to parenteral product containers, blow-fill-seal (BFS) plastic packages are receiving wide acceptance at medical treatment terminals due to various advantages on safety handling, foreign matter contamination and waste treatment aspects compared to glass containers. It is quite important to test leakage on the BFS package, as microbial contamination must be strictly avoided. At present, the highest sensitivity leakage detection method is direct current impressed high voltage leak detector (HVLD) system. It has been, however, required from the system that electric conductivity of the content to be not less than 20μS/cm for leakage detection. In the present work, pinhole sizes of 5-10μm were detected by the HVLD applied to water for injection of conductivity not more than 2μS/cm. Results indicate that the HVLD is feasible to apply for inline inspection of all products manufactured by the BFS process.

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© 2001 Parenteral Drug Association Japan Chapter
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